Studying Cells Collected Through Ductal Lavage in Women Undergoing Surgery for Ductal Carcinoma In Situ or Other Breast Cancer

NCT00896857 | Completed

• 3 other identifiers: CCCWFU-74A04CDR0000579246CCCWFU-BG04-063
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is evaluating cells collected through ductal lavage in women undergoing surgery for ductal carcinoma in situ or other breast cancer.

Conditions

Breast Cancer

Keywords

breast cancer; ductal breast carcinoma in situ

Outcome Measures

Primary Outcomes (4)

• Expression pattern of the programmed cell death (PCD) regulatory genes bcl-2, bax, and bcl-xL in primary ductal carcinoma in situ (DCIS) cultures

• Induction of PCD by antisense oligonucleotides and/or tamoxifen citrate in primary DCIS cell cultures

• Expression pattern of the PCD regulatory genes bcl-2, bax, and bcl-xL in cells obtained by breast ductal lavage

• Induction of PCD by antisense oligonucleotides and/or tamoxifen citrate in cells obtained by breast ductal lavage

Interventions

RNA analysis GENETIC

polymerase chain reaction GENETIC

protein expression analysis GENETIC

reverse transcriptase-polymerase chain reaction GENETIC

western blotting GENETIC

immunoenzyme technique OTHER

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

breast duct lavage PROCEDURE

Eligibility Criteria

• Age: Up to 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women Undergoing Surgery for Ductal Carcinoma In Situ or Other Breast Cancer

DISEASE CHARACTERISTICS: * Agrees to undergo breast surgical procedure AND meets one of the following criteria: * Scheduled to undergo breast biopsy based on suspicious mammographic or clinical breast examination findings * Diagnosis of ductal carcinoma in situ (DCIS) or carcinoma in the breast to be studied (opposite breast may also be studied) * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Pre- or post-menopausal * Not currently pregnant or pregnant within the past 12 months * Must not have lactated within the past 12 months * No active infection or inflammation in the breast to be studied * No known allergy to lidocaine, prilocaine, or marcaine (bupivacaine) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior subareolar surgery or other breast procedure that may disrupt the ductal system within 2 cm of the nipple in the breast to be studied * No prior breast implant that disrupts the ductal architecture in the breast to be studied * No prior silicone injections in the breast to be studied * No prior radiotherapy to the breast to be studied * No chemotherapy within the past 6 months * Concurrent prophylactic chemotherapy allowed * No concurrent participation in another research study that may conflict with or affect the outcome of this study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Interventions

Polymerase Chain Reaction; Reverse Transcriptase Polymerase Chain Reaction; Blotting, Western; Immunoenzyme Techniques; Immunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Electrophoresis; Chemistry Techniques, Analytical; Electrochemical Techniques; Immunoblotting; Immunoassay; Immunologic Techniques; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques

Study Officials

• Patrick P. Koty, PhD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: April 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 15, 2017

Record last verified: 2017-03